drugset / Trial / NCT01678690
An Exploratory Study of Gemcitabine Hydrochloride Oral Formulation (D07001-F4) in Subjects With Malignant Tumors
NaSingle-groupOpen-label
Summary
Open-label, Phase 0, dose-escalation study of 3 successive cohorts (3 subjects per cohort), to determine and characterize the plasma PK of gemcitabine HCl oral formulation (D07001-F4) administered once on Day 1 with 7 Days of study follow-up. In addition, oral tolerability and safety will also be assessed during this 1-week period.
Timeline
- Start
- 2012-08
- Primary completion
- 2014-04
- Completion
- 2014-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 2 mg | Oral |
| Subject | Gemcitabine | Small molecule | 5 mg | Oral |
| Subject | Gemcitabine | Small molecule | 10 mg | Oral |